AC ADAPTER:MODELS 9525,9526,9527— 510(k) K781535

Name: FDA 510(k) clearance K781535
Creator: U.S. Food and Drug Administration
Published: 1978-09-15

Substantially Equivalent

Edwards Laboratories

FDA 510(k) clearance K781535 for AC ADAPTER:MODELS 9525,9526,9527, Substantially Equivalent on 1978-09-15. Applicant: Edwards Laboratories. Device class: 2.

Clearance details

Applicant: Edwards Laboratories
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 1978-09-06
Decision date: 1978-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K801552 — MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR1980-07-28
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K792441 — CARPENTIER-EDWARDS FLEX. ANNULOPLASTY1980-03-17
K792034 — INTEGRAL DISPOSABLE HOLDER CARPENTIER1979-12-07
K790047 — CARDIAC OUTPUT COMPUTER, MDEL 9520A1979-02-26

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